General AnesthesiaNCT06979206
Effects of Binaural Beats on Inhaled Anesthetic Requirements During General Anesthesia in Pediatric Patients
A study testing Application of Binarual Beat in people with General Anesthesia and Children, run by Seoul National University Hospital.
Trial summary
The hypothesis of this study is that continuously delivering binaural beats with a phase difference corresponding to the slow-delta frequency band during anesthesia in pediatric patients can clinically and significantly reduce the required dose of the commonly used inhalational anesthetic, sevoflurane. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- General Anesthesia, Children
- What is being tested?
- Application of Binarual Beat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients under 3 years of age undergoing superficial surgery lasting more than 1 hour under general anesthesia (e.g., nevus excision, polydactyly/syndactyly surgery, dermoid cyst excision, thyroglossal duct cyst excision, preauricular fistula excision, inguinal hernia repair, orchiopexy, other mass excisions, strabismus surgery, etc.).
- American Society of Anesthesiologists (ASA) physical status classification I or II.
Who cannot join
- Neonates or premature infants
- Children with hearing impairment or currently using hearing aids
- Children with neurological disorders
- Children with respiratory diseases
- Children undergoing neurosurgery or cardiac surgery
- Other patients deemed inappropriate for inclusion in the clinical trial at the discretion of the investigator or study staff
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ji-Hyun Lee, MD, PhD contact
About this study
Official title: Effects of Binaural Beats on Inhaled Anesthetic Requirements During General Anesthesia in Pediatric Patients: A Prospective, Randomized Controlled Trial
The hypothesis of this study is that continuously delivering binaural beats with a phase difference corresponding to the slow-delta frequency band during anesthesia in pediatric patients can clinically and significantly reduce the required dose of the commonly used inhalational anesthetic, sevoflurane. To test this hypothesis, the study will compare the average end-tidal concentration of sevoflurane between a group exposed to continuous binaural beats (approximately 1 Hz phase difference) during surgery and a control group not exposed to such auditory stimulation.
- Conditions
- General Anesthesia, Children
- Being tested
- Application of Binarual Beat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Binarual BeatOther
The binaural beat audio file consists of pure tones at 431 Hz in the left ear and 432 Hz in the right ear, delivered via earphones continuously until the end of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Binarual beat group | Experimental | In this group, a binaural beat audio file is applied throughout the maintenance of anesthesia. The binaural beat consists of pure tones at 431 Hz in the left ear and 432 Hz in the right ear, delivered via earphones continuously until the end of anesthesia. Anesthesia is maintained with sevoflurane, and its concentration is adjusted to maintain a Patient State Index (PSI; SEDLine®; Masimo Corp., Irvine, USA) between 20 and 50. At the end of surgery, sevoflurane administration is discontinued, and ondansetron 0.1 mg/kg, acetaminophen 15 mg/kg, ketorolac 0.5 mg/kg, and a neuromuscular reversal agent are administered to facilitate emergence from anesthesia. Receives: Other: Application of Binarual Beat |
| Control group | No intervention | This group undergoes anesthesia using the conventional method, with maintenance of anesthesia achieved using sevoflurane. The concentration of sevoflurane is adjusted to maintain a Patient State Index (PSI; SEDLine®; Masimo Corp., Irvine, USA) between 20 and 50. At the end of surgery, sevoflurane administration is discontinued, and ondansetron 0.1 mg/kg, acetaminophen 15 mg/kg, ketorolac 0.5 mg/kg, and a neuromuscular reversal agent are administered to facilitate emergence from anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average EtSevo (end-tidal sevoflurane concentration, vol%) maintained during surgery.
Measured: During surgery, more than 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start30 May 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hyun Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979206
- Sponsor's protocol ID
- 2501-127-1610
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Binaural Beats on Inhaled Anesthetic Requirements During General Anesthesia in Pediatric Patients: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06979206
- Acronym / sponsor ID
- 2501-127-1610
- Conditions
- General Anesthesia, Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this study is that continuously delivering binaural beats with a phase difference corresponding to the slow-delta frequency band during anesthesia in pediatric patients can clinically and significantly reduce the required dose of the commonly used inhalational anesthetic, sevoflurane. To test this hypothesis, the study will compare the average end-tidal concentration of sevoflurane between a group exposed to continuous binaural beats (approximately 1 Hz phase difference) during surgery and a control group not exposed to such auditory stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binarual beat group | Experimental | Other: Application of Binarual BeatIn this group, a binaural beat audio file is applied throughout the maintenance of anesthesia. The binaural beat consists of pure tones at 431 Hz in the left ear and 432 Hz in the right ear, delivered via earphones continuously until the end of anesthesia. Anesthesia is maintained with sevoflurane, and its concentration is adjusted to maintain a Patient State Index (PSI; SEDLine®; Masimo Corp., Irvine, USA) between 20 and 50. At the end of surgery, sevoflurane administration is discontinued, and ondansetron 0.1 mg/kg, acetaminophen 15 mg/kg, ketorolac 0.5 mg/kg, and a neuromuscular reversal agent are administered to facilitate emergence from anesthesia. |
| Control group | No intervention | –This group undergoes anesthesia using the conventional method, with maintenance of anesthesia achieved using sevoflurane. The concentration of sevoflurane is adjusted to maintain a Patient State Index (PSI; SEDLine®; Masimo Corp., Irvine, USA) between 20 and 50. At the end of surgery, sevoflurane administration is discontinued, and ondansetron 0.1 mg/kg, acetaminophen 15 mg/kg, ketorolac 0.5 mg/kg, and a neuromuscular reversal agent are administered to facilitate emergence from anesthesia. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients under 3 years of age undergoing superficial surgery lasting more than 1 hour under general anesthesia (e.g., nevus excision, polydactyly/syndactyly surgery, dermoid cyst excision, thyroglossal duct cyst excision, preauricular fistula excision, inguinal hernia repair, orchiopexy, other mass excisions, strabismus surgery, etc.).
- American Society of Anesthesiologists (ASA) physical status classification I or II.
Key exclusion criteria (6 listed)
- Neonates or premature infants
- Children with hearing impairment or currently using hearing aids
- Children with neurological disorders
- Children with respiratory diseases
- Children undergoing neurosurgery or cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of Binarual BeatThe binaural beat audio file consists of pure tones at 431 Hz in the left ear and 432 Hz in the right ear, delivered via earphones continuously until the end of anesthesia. | Other | Binarual beat group |
Primary outcome
The average EtSevo (end-tidal sevoflurane concentration, vol%) maintained during surgery.
Time frame: During surgery, more than 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ji-Hyun Lee, MD, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Application of Binarual Beat in people with General Anesthesia and Children, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji-Hyun Lee, MD, PhD (+82-10-7665-8848, muslab6@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average EtSevo (end-tidal sevoflurane concentration, vol%) maintained during surgery. (time frame: During surgery, more than 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.